Eli Lilly’s COVID-19 antibody treatment is promising

A Survey In New England Journal of Medicine (((NEJMThis week, Eli Lilly’s COVID-19 convalescent virus-neutralizing monoclonal antibody therapy (LY-CoV555) reduced viral load, reduced symptom severity, and did not have a serious adverse effect on outpatients. is showing.

Phase 2 study data confirm preliminary results In September From a smaller cohort of outpatients (people visiting the clinic) with similar results.

Animal experiments with neutralizing antibodies have promising results that significantly reduce the viral load in the upper and lower respiratory tracts, where SARS-CoV-2, the virus that causes COVID-19, is thought to bind and cause disease. Is shown. Neutralizing antibodies, such as LY-CoV555, attach to the SARS-CoV-2 spike protein to prevent virus attachment and virus invasion into cells of the upper and lower respiratory tract.

In a study to prevent viral attachment and cell invasion with SARS-CoV-2 neutralizing antibody (BLAZE-1), outpatients recently diagnosed with mild or moderate COVID-19 were given various doses of LY-CoV555. did. This trial is part of an ongoing study with multiple treatment groups that will eventually enroll more than 800 participants.

From June 17 to August 21, researchers found 452 COVID-19-positive patients with mild or moderate symptoms in 41 locations in the United States out of three doses of LY-CoV555. One dose was randomly assigned to the group injected intravenously for 1 hour (700-, 2,800 mg, and 7,000 mg). [mg]309 patients) or placebo (143 patients). Patients were evaluated for viral load after infusion on day 11 and clinical outcomes such as hospitalization, ER visits, and death by day 29, and treatment safety.

Reduced viral load, severity of symptoms

The authors of the study found that patients receiving a dose of 2,800 mg had significantly reduced viral load, 3.4-fold lower than baseline placebo levels (-0.53, 95% confidence interval). [CI], -0.98 ~ -0.08; P = 0.02). A slight decrease in viral load was observed in patients receiving doses of 700 mg and 7,000 mg.

Patients receiving LY-CoV555 had less severe symptoms on days 2-6 than in the placebo group (from “0” in the absence of symptoms to “3” in the case of severe symptoms. Step by step). Changes from baseline symptom scores remained favorable in the treatment group compared to placebo until day 11, with similar safety profiles in both groups.

COVID-19-related hospitalization or emergency room visit rates were 1.6% (5/309 patients) in the antibody group and 6.3% (9/143 patients) in the placebo group, with increased virus clearance and decreased hospitalization rates. Suggests a connection with. Hospitalization rates were more pronounced in patients aged 65 years and older, with an obesity index of 35 and above, 4% and 15% in the antibody and placebo groups, respectively.

Patients in the LY-CoV555 group had no serious adverse events compared to one in the placebo group. The rates of all adverse events were similar: 22.3% in the treatment group and 24.5% in the placebo group.

“These data show that treatment is safe,” the study authors conclude. “Patients who received LY-CoV555 were less hospitalized, less symptomatic, and most prominent in the high-risk cohort than those who received placebo. These results were observed in this study. LY-CoV555 will be a useful treatment for emergency use in patients recently diagnosed with Covid-19, as confirmed by additional analysis of. “

Inpatient exams have been discontinued

The interim analysis will be conducted one day after the National Institutes of Health. Abolished clinical trials Results from LY-CoV555 for 326 inpatients found that it was unlikely to improve outcomes in this patient population.

Suspension of study enrollment by the Data and Safety Monitoring Committee (DSMB) October 13 when a preset safety boundary was crossed to indicate differences in clinical status between inpatients in the treatment and placebo groups. Triggered by. Ultimately, no significant safety concerns were identified, and DSMB’s recommendation to discontinue the trial this week was due to the lack of clinical benefit of inpatients.

Eli Lilly scientists have found that inpatients, in contrast to outpatients, have a longer course of infection, more severe symptoms, and are treated differently than non-hospitalized patients. I think there may be a shortage of profits.

“For these reasons, inpatients may develop their own endogenous antibody response and be in a stage of disease characterized by an inflammatory response to the virus, which is a supplement to the patient’s own immune system. The benefits of antibodies may be small, “the company wrote on October 14. news release..

Possibility of early intervention

Eli Lilly researchers are convinced that LY-CoV555 may prevent the progression of disease in early-stage COVID-19 patients. Phase 2 trials in outpatients and Phase 3 trials focusing on antibody therapy in residents and care facility staff are ongoing.

“It is important to treat people with COVID-19 as soon as possible after diagnosis to prevent the development of more serious illnesses,” said Dr. Peter Chen of Cedars-Sinai, Los Angeles, and the lead author of the NEJM study. Eli Lily Press release this week. “Our findings show that neutralizing antibodies may help in this early stage of intervention,” he added.